Antibacterial coating treatment method for suture with needle

Abstract

The present invention relates to a method for treating a needle-carrying suture with an antibacterial coating. The needle-carrying suture is composed of a connected suture needle and a suture. After a triclosan coating is formed on the surface of the suture needle, the needle-carrying suture is placed in a package and sterilized with ethylene oxide and dried in sequence. After the treatment is completed, the antibacterial coating is transferred from the suture needle to the suture. The method for treating a needle-carrying suture with an antibacterial coating of the present invention forms a uniform antibacterial coating with a high adhesion amount on the suture, which can ensure that the antibacterial agent directly acts on the suture needle and the suture that are in the most direct contact with the surgical site, thereby increasing the antibacterial property and effectively inhibiting the colonization of bacteria on the suture and the inner package.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices and relates to an antibacterial coating treatment method for a suture with a needle. Background Art

[0002] Surgical sutures are essential medical consumables used for suturing and ligating various surgical incisions. Traditional sutures may become a breeding ground for bacteria, thereby increasing the risk of infection. To address this risk, antibacterial sutures are used in sutures. Antibacterial sutures can effectively kill or inhibit bacteria that may cause infection. Sutures form an antibacterial zone at the suture site, significantly reducing local bacterial reproduction and reducing the incidence of infection. This improves the healing quality of surgery and accelerates patient recovery. The use of antibacterial sutures can also reduce the need for systemic antibiotics, thereby reducing patients' dependence on antibiotics, reducing possible side effects, and the development of antibiotic resistance.

[0003] However, in the prior art, the suture is usually immersed in an antibacterial solution to form an antibacterial coating. Although the antibacterial effect can be achieved to a certain extent, the triclosan adhesion on a suture is uneven and the difference is quite obvious. This may be because the mechanical stress of the suture is relatively small, and the triclosan coating on the suture will be worn to a certain extent during the assembly process such as winding the wire in the winding reel; and because the suture is relatively long, the time and environment of the suture immersion will also lead to unstable triclosan colonization on the suture.

[0004] In addition, patent US11707272B2 discloses a packaged antibacterial medical device, which uses a patch as an antibacterial material reservoir, is pasted on absorbent paper, and is colonized on sutures through sterilization transfer. However, the patch is attached externally and has no direct contact with the sutures. Moreover, the location of the patch is blocked from the sutures, which will reduce the colonization content of triclosan on the sutures.

[0005] Therefore, it is of great significance to study an antibacterial coating treatment method for needle sutures to solve the problems existing in the prior art. Summary of the invention

[0006] The purpose of the present invention is to solve the problems existing in the prior art and provide an antibacterial coating treatment method for a suture with a needle.

[0007] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0008] A method for treating a needle-attached suture with an antimicrobial coating. The needle-attached suture consists of a connected suture needle and a suture thread. After a triclosan coating is formed on the surface of the suture needle, the needle-attached suture thread is placed in a package and sterilized and dried with ethylene oxide in sequence. Under the sterilization and drying conditions, the triclosan in the coating can be decomposed or expanded, thereby causing the triclosan to be released from the needle. After the treatment is completed, the antimicrobial coating is transferred from the suture needle to the suture thread.

[0009] As the preferred technical solution:

[0010] In the antibacterial coating treatment method for a needle suture as described above, ethylene oxide sterilization is carried out under certain temperature and humidity conditions, the temperature is above 50°C, and the relative humidity is 50-60%. Appropriate humidity is conducive to the hydrolysis reaction of ethylene oxide and enhances the sterilization effect; the amount of ethylene oxide used is 400-800 grams per cubic meter of sterilization space.

[0011] In the method for treating a needle suture with an antimicrobial coating as described above, the ethylene oxide sterilization process adopts alternating negative and positive pressures. The negative pressure is -50 to -70 kPa, and the negative pressure is maintained for 15 to 30 minutes, which helps to prevent leakage of ethylene oxide and promote its penetration. The positive pressure is 80 to 90 kPa, and the positive pressure is maintained for 15 to 40 minutes to ensure that ethylene oxide is in full contact with the suture for sterilization. The number of alternating cycles of negative and positive pressure is 3 to 5 times, and the time interval between each two cycles is 15 to 30 minutes.

[0012] The antimicrobial coating treatment method for a needle suture as described above has a sterilization time of 4 to 8 hours.

[0013] In the above-mentioned method for treating an antibacterial coating on a suture with a needle, the drying process parameters are: temperature 50-60°C, vacuum degree 0.01-0.1 kPa, and time 4-9 hours.

[0014] An antimicrobial coating treatment method for a suture with a needle as described above, wherein the packaging is a double-layer packaging, the inner packaging is an aluminum foil bag, and at least one side of the outer packaging is TYVEK;

[0015] The suture with needle is placed in a tray, covered with absorbent paper and placed in the inner package. The inner package is opened and placed in the outer package, and then the outer package is sealed and placed in an ethylene oxide sterilization box for sterilization. After sterilization, it is dried. During the sterilization process, the inner package has an opening to allow the sterilization gas ethylene oxide to enter smoothly. After sterilization and drying are completed, the inner package is sealed again.

[0016] In the above-mentioned method for treating sutures with needles with antimicrobial coating, the tray is rectangular in shape, and two through-holes are provided on the tray to ensure gas circulation during sterilization; a needle seat support is provided in the middle area inside the tray for placing suture needles, and each corner of the needle seat support is rounded to prevent cutting, and the needle seat support has a wire groove; a winding column is provided in the edge area inside the tray, and the number of winding columns is at least 4, and each winding column has at least two wire grooves for winding the sutures. The sutures are wound in a fixed position in the tray, which avoids overlap between the sutures and allows the sutures to be more evenly exposed to the antimicrobial agent during treatment.

[0017] In the method for treating a suture with a needle using an antibacterial coating as described above, the specific process of forming a triclosan coating on the surface of the suture needle is as follows: under a sterile state at room temperature, a triclosan coating liquid is placed in a sterile plate, and the suture needle is immersed in the plate by soaking, and taken out after soaking for 20 to 80 minutes, and allowed to stand until dry.

[0018] In the above-mentioned method for treating a suture with a needle with an antibacterial coating, the triclosan coating liquid is prepared by first dissolving triclosan in ethyl acetate, then adding a coating solvent, and mixing them uniformly to obtain the triclosan coating liquid;

[0019] The mass percentage of triclosan relative to ethyl acetate is 1-20%, and the mass percentage of the coating solvent relative to the total amount of triclosan and ethyl acetate is 50%;

[0020] It’s just that the coating effect in triclosan and ethyl acetate is not good, and additional coating solvent is needed to drive its adsorption on the needle.

[0021] Principle of the invention:

[0022] In the present invention, the triclosan coating on the suture needle is transferred to the suture thread during the sterilization and drying process, so that a uniform antibacterial coating with a high adhesion amount is formed on the suture thread. The specific implementation mechanism is as follows:

[0023] 1. Close-range action: Triclosan molecules attract each other through van der Waals forces. Although the range of intermolecular forces, such as van der Waals forces, is relatively small, they can play a strong role in the local area where the suture needle and the suture are in direct contact. Even if the suture is very long, triclosan molecules near the contact point between the suture needle and the suture can be quickly transferred to the suture through these close-range forces. For example, when the triclosan coating on the suture needle contacts the suture, within a few millimeters or even microns around the contact point, the triclosan molecules can quickly attach to the surface of the suture by intermolecular forces.

[0024] 2. Formation of high-concentration areas: A relatively high-concentration triclosan area will be formed at the direct contact site between the suture needle and the suture. Since the coating on the suture needle contains a relatively high concentration of triclosan, when they come into contact with the suture, a local high-concentration area will be formed near the contact point. The triclosan molecules in this area will have greater motivation to diffuse to other parts of the suture. For example, just like a drop of ink spreading on paper, the ink concentration is highest at the initial contact site, and then gradually diffuses to the surrounding area. In the contact between the suture needle and the suture, triclosan will also diffuse from the high-concentration contact site to other parts of the suture, thereby achieving coverage of longer sutures.

[0025] Compared with the prior art method of using an adsorbent to transfer an antibacterial coating to a needle-carrying suture, because the suture needle is closer to the suture, triclosan can contact the suture more directly and quickly when it evaporates, and there is no obstruction when the suture contacts the suture needle. Since there is no obstruction, when triclosan diffuses in all directions, the suture may contact the triclosan molecules in all directions and have the opportunity to interact with the triclosan molecules, thereby increasing the contact area and contact opportunity and increasing the adhesion content on the thread.

[0026] Beneficial effects:

[0027] (1) The antibacterial coating treatment method of a needle-attached suture thread of the present invention can ensure that the antibacterial agent can directly act on the suture needle and suture thread that are in the most direct contact with the surgical site, thereby increasing the antibacterial property and effectively inhibiting the colonization of bacteria on the suture thread and the inner packaging;

[0028] (2) In the present invention, a method for treating a needle-attached suture with an antimicrobial coating is provided. Since triclosan is pre-treated and colonized on the needle, the source of the antimicrobial agent is the needle itself, and no additional antimicrobial agent source device is required.

[0029] (3) The present invention provides a method for treating a needle suture with an antibacterial coating, wherein the triclosan on the needle suture after treatment has good adhesion stability and uniform content distribution. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 This is a top view of the tray;

[0031] Figure 2 It is a side view of the tray;

[0032] Figure 3 This is a comparison chart of triclosan content in two methods: suture needle and adsorption paper;

[0033] Figure 4 A comparison of triclosan content in different parts of a single suture;

[0034] Among them, 1-winding column, 2-fixing component, 3-tail end winding column, 4-needle seat support, 5-air vent I, 6-air vent II, 7-wire groove. DETAILED DESCRIPTION

[0035] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content taught by the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms fall within the scope limited by the appended claims of the application equally.

[0036] A method for treating an antibacterial coating of a suture with a needle, wherein the suture with a needle is composed of a connected suture needle and suture thread, and the specific treatment steps are as follows:

[0037] (1) first dissolving triclosan in ethyl acetate, then adding a coating solvent (MED-2214 and xylene mixed, the mass percentage of MED-2214 relative to xylene being 0.5-10%), and mixing evenly to obtain a triclosan coating liquid;

[0038] The mass percentage of triclosan relative to ethyl acetate is 1-20%, and the mass percentage of the coating solvent relative to the total amount of triclosan and ethyl acetate is 50%;

[0039] (2) Under sterile conditions at room temperature, place the triclosan coating liquid in a sterile dish, immerse the suture needle in the dish, soak for 20 to 80 minutes, take it out, and let it stand until it is dry, so that a triclosan coating is formed on the surface of the suture needle;

[0040] (3) After the triclosan coating is formed on the surface of the suture needle, the suture with the needle is placed on a tray, covered with absorbent paper and placed in an aluminum foil bag. The aluminum foil bag is opened and placed in an outer package with at least one side covered with TYVEK. The outer package is then sealed and placed in an ethylene oxide sterilization box. Ethylene oxide sterilization is performed for 4 to 8 hours at a temperature above 50°C and a relative humidity of 50 to 60%.

[0041] The tray is rectangular in shape, with two through-going air holes on it; a needle seat support is provided in the middle area inside the tray for placing suture needles, and the needle seat support has a wire groove; a winding post is provided in the edge area inside the tray, and the number of winding posts is at least 4, and each winding post has at least two wire grooves for winding suture wires;

[0042] The amount of ethylene oxide used is 400-800 grams per cubic meter of sterilization space; the ethylene oxide sterilization process adopts the method of alternating negative pressure and positive pressure, the negative pressure is -50-70 kPa, the negative pressure is maintained for 15-30 minutes, the positive pressure is 80-90 kPa, and the positive pressure is maintained for 15-40 minutes; the number of alternating cycles of negative pressure and positive pressure is 3-5 times, and the time interval between each two cycles is 15-30 minutes;

[0043] (4) The product of step (3) is dried at a temperature of 50-60° C. and a vacuum degree of 0.01-0.1 kPa for 4-9 hours. After the drying is completed, the antibacterial coating is transferred from the suture needle to the suture thread.

[0044] The following is a specific embodiment to illustrate the antibacterial coating treatment method of a suture with a needle of the present invention, which is as follows:

[0045] A method for treating an antibacterial coating of a suture with a needle, wherein the suture with a needle is composed of a connected suture needle and suture thread, and the specific treatment steps are as follows:

[0046] (1) first dissolving triclosan in ethyl acetate, then adding it into a coating solvent (MED-2214 and xylene are mixed, and the mass percentage of MED-2214 relative to xylene is 1%), and mixing them evenly to obtain a triclosan coating liquid;

[0047] The mass percentage of triclosan relative to ethyl acetate is 10%, and the mass percentage of the coating solvent relative to the total amount of triclosan and ethyl acetate is 50%;

[0048] (2) Under sterile conditions at room temperature, place the triclosan coating liquid in a sterile plate, immerse the suture needle in the plate, take it out after immersion for 60 minutes, and let it stand until it is dry, so that a triclosan coating is formed on the surface of the suture needle;

[0049] (3) After the triclosan coating is formed on the surface of the suture needle, the suture with the needle is placed in a tray, covered with absorbent paper and placed in an aluminum foil bag. The aluminum foil bag is opened and placed in a 150×80 mm TYVEK bag. The TYVEK bag is then sealed and placed in an ethylene oxide sterilization box for ethylene oxide sterilization at a temperature of 50°C and a relative humidity of 50%;

[0050] like Figure 1~2As shown, the tray is rectangular in shape, and two through-holes are provided on the tray, which are respectively marked as vent hole Ⅰ 5 and vent hole Ⅱ 6; a needle seat support 4 is provided in the middle area inside the tray for placing the suture needle, and the needle seat support 4 has a wire groove; a winding column 1 is provided in the edge area inside the tray, and the winding column 1 at the four corners is provided with a fixing member 2, which is the bayonet position of the absorbent paper, and each winding column 1 has two wire grooves 7 for winding the suture wire; the specific winding method is: the tail end of the suture wire starts to be wound around the tail end winding column 3 for two turns and is fixed, and then starts to be wound according to Figure 1 The winding method shown is that each winding post has two wire grooves 7 for fixing the position of the wire, ensuring that the suture wire will not overlap after being wound twice, and the final suture needle is fixed on the needle seat pillar 4;

[0051] The amount of ethylene oxide used is 500 grams per cubic meter of sterilization space; the ethylene oxide sterilization process adopts the method of alternating negative pressure and positive pressure, the negative pressure is -60kPa, the negative pressure is maintained for 20 minutes, the positive pressure is 80kPa, and the positive pressure is maintained for 25 minutes; the number of alternating cycles of negative pressure and positive pressure is 4 times, and the time interval between each two cycles is 20 minutes;

[0052] (4) The product of step (3) is dried at a temperature of 56° C. and a vacuum degree of 0.02 kPa for 5 hours. After the drying is completed, the antibacterial coating is transferred from the suture needle to the suture thread.

[0053] In order to verify the stability of the antibacterial coating on the needle-carrying sutures after the above treatment, the antibacterial coating on the needle-carrying sutures was transferred under the same conditions of quantitative triclosan content. Five suture needles were transferred to the sutures with 1# threads and five adsorption paper sheets were transferred to the sutures. The suture needles were made of 12Cr18Ni9 stainless steel, with a needle length of 36 mm and a needle type of 1 / 2 arc. The sutures were PGLA910 sutures with a specification of 1# and a length of 65 cm. The triclosan residue on the sutures was first extracted by derivatization treatment, and the triclosan residue was determined by gas chromatograph. The specific operation was as follows:

[0054] (1.1) Take a #1 thread transferred from the suture needle to the suture thread, cut it into pieces, and mix it. Weigh 1g of the sample from the mixed sample to an accuracy of 0.01g, place it in a 150mL stoppered conical flask, add 25mL of methanol, and ultrasonically extract it at 40℃ for 30min. Collect the extract into a round-bottom flask. Ultrasonic extract the residue with 25mL of methanol for 30min again, and combine the extracts. Concentrate the extract in the round-bottom flask to nearly 1mL at 40℃ using a rotary evaporator, and then slowly blow it to near dryness with nitrogen.

[0055] (1.2) Extract by derivatization. Wash the residue in the round-bottom flask with 50 mL of sodium tetraborate solution several times. Transfer the washing solution to a 150 mL stoppered conical flask. Add 1 mL of acetic anhydride and oscillate at room temperature at a speed of 150 times / min. Add 10 mL of n-hexane accurately and continue to oscillate for 30 minutes. Transfer to a 125 mL separatory funnel, shake well and let stand, and discard the lower aqueous phase. Wash the upper organic phase with 30 mL of sodium tetraborate solution, shake well and let stand, discard the lower aqueous phase, and repeat the washing three times. Take the upper organic phase and filter it through a filter membrane for gas chromatography analysis.

[0056] a) Chromatographic column: HP-5 quartz capillary column, 30 m (column length) × 0.32 mm (inner diameter) × 0.25 μm (film thickness);

[0057] b) Column temperature: 150 ℃ → 280 ℃ (1.5 min); (20 ℃ / min);

[0058] c) Inlet temperature: 250 °C;

[0059] d) Detector temperature: 280 °C;

[0060] e) Carrier gas: nitrogen, purity>99.999%; flow rate 1.7 mL / min;

[0061] f) Injection volume: 1.0 μL;

[0062] g) Injection method: splitless injection.

[0063] (1.3) Standard working curve standard working solution;

[0064] The derivatized solution was injected and measured according to the above conditions (1.2), and a standard working curve was drawn with triclosan concentration as the horizontal axis and peak area as the vertical axis.

[0065] (1.4) Blank test;

[0066] Except that no sample is added, the above determination steps are followed; the triclosan content is calculated according to the following formula:

[0067] x =[( c - c0 ) × V × F] / m;

[0068] x——the content of triclosan in the sample, in milligrams per kilogram (mg / kg);

[0069] c——Triclosan concentration of the sample solution read from the standard working curve, in milligrams per liter (mg / L);

[0070] c0——the concentration of triclosan read from the standard working curve in the blank test, in milligrams per liter (mg / L);

[0071] V——The final fixed volume of the sample, in milliliters (mL);

[0072] F——dilution factor of the sample;

[0073] m——the mass of the sample, in grams (g);

[0074] The other 9 sutures were processed in the same manner as above; the specific experimental results are shown in Table 1 below:

[0075] Table 1

[0076] Number of experiments Adsorption paper (ppm) Suture needle transfer (ppm) 1 191 201 2 165 196 3 178 202 4 196 198 5 152 201

[0077] like Figure 3 As shown, it can be found that the triclosan content on the suture line is more stable when triclosan is transferred through a suture needle. Compared with the transfer with a suture needle, the use of the adsorbent may result in uneven adsorption, resulting in a higher shedding rate of triclosan transferred from some coatings under the same conditions, and the stability of multiple tests is significantly poor.

[0078] The following experiment was designed to compare the uniformity of triclosan content distribution after triclosan was implanted on the suture by three different methods: the first was to transfer directly from the suture needle coated with triclosan to the suture (i.e., the solution of the present invention); the second was to transfer to the suture using a triclosan adsorbed paper sheet; and the third was to directly immerse the suture to form a triclosan coating. The experiment was carried out under strictly controlled temperature, humidity, and pressure conditions to ensure that the operating environment of the three methods was consistent. The triclosan content was determined using a gas chromatograph.

[0079] Determination method: Take the same triclosan content of the needle suture, one is the suture needle transferred to the suture 1# thread (corresponding to Table 2 and Figure 4 1 is the "suture needle coating" in Table 2), 1 is the 1# line transferred to the suture line by the adsorption paper (corresponding to Table 2 and Figure 4 1 is the "absorbent paper" in Table 2), 1 is the 1# thread directly soaked on the suture to form a triclosan coating (corresponding to Table 2 and Figure 4 The residual triclosan content of the suture was first extracted by derivatization treatment, and a section of suture was taken from 2 cm, 22 cm, 34 cm, and 45 cm away from the needle end of the three sutures, and the residual triclosan content was determined by gas chromatography. The specific operation was the same as above; the experimental results are shown in Table 2 below:

[0080] Table 2

[0081]

[0082] like Figure 4 As shown, it can be found that the uniformity of triclosan distribution in the adsorbent paper and suture coating is significantly poorer compared to the suture needle transfer.

Claims

1. A method for treating a suture with an antibacterial coating, characterized in that: The needle-attached suture is composed of a connected suture needle and a suture thread. After the triclosan coating is formed on the surface of the suture needle, the needle-attached suture thread is placed in a package and sterilized with ethylene oxide and dried in sequence. After the treatment is completed, the antibacterial coating is transferred from the suture needle to the suture thread. The specific process of forming the triclosan coating on the surface of the suture needle is as follows: under a sterile state at room temperature, the triclosan coating liquid is placed in a sterile plate, the suture needle is immersed in the plate by soaking, and taken out after soaking for 20 to 80 minutes, and allowed to stand until dry; The preparation process of the triclosan coating liquid is as follows: firstly dissolving triclosan in ethyl acetate, then adding a coating solvent, and mixing evenly to obtain the triclosan coating liquid; The mass percentage of triclosan relative to ethyl acetate is 1-20%, and the mass percentage of the coating solvent relative to the total amount of triclosan and ethyl acetate is 50%; The coating solvent is a silicon coating solvent.

2. The method for treating a suture with an antibacterial coating according to claim 1, characterized in that: Ethylene oxide sterilization is carried out under certain temperature and humidity conditions, with the temperature above 50°C and the relative humidity between 50% and 60%.

3. The method for treating a suture with an antibacterial coating according to claim 2, characterized in that: The ethylene oxide sterilization process uses alternating negative and positive pressures, with the negative pressure being -50~-70kPa and the positive pressure being 80~90kPa.

4. The method for treating a suture with an antibacterial coating according to claim 3, characterized in that: The sterilization time is 4~8h.

5. The method for treating a suture with an antibacterial coating according to claim 1, characterized in that: The drying process parameters are: temperature 50~60℃, vacuum degree 0.01~0.1kPa, and time 4~9h.

6. The method for treating a suture with an antibacterial coating according to claim 1, characterized in that: The packaging is double-layer packaging, the inner packaging is an aluminum foil bag, and at least one side of the outer packaging is TYVEK; The suture with needle is placed in a tray, covered with absorbent paper and placed in an inner package, the inner package is opened and placed in an outer package, and then the outer package is sealed and placed in an ethylene oxide sterilization box for sterilization. After sterilization, it is dried.

7. The method for treating a suture with an antibacterial coating according to claim 6, characterized in that: The tray is rectangular in shape and has two through-going air holes. A needle seat support is provided in the middle area inside the tray for placing suture needles, and the needle seat support has a wire groove. A winding post is provided in the edge area inside the tray, and the number of winding posts is at least 4. Each winding post has at least two wire grooves for winding the suture thread.

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